FASENRA is indicated as an add-on maintenance treatment of patients 12 years and older with severe eosinophilic asthma.FASENRA is not indicated for treatment of other eosinophilic conditions or for the relief of acute bronchospasm or status asthmaticus.

POWER TO PREVENT EXACERBATIONS

WITH BETTER BREATHING AFTER THE FIRST DOSE*1-4

FASENRA is proven to reduce annual exacerbation rate and improve lung function in patients with severe eosinophilic asthma. Improvements in lung function were observed as early as Week 4.*1-4

*Statistical significance for FEV1 improvement was established at end of treatment. Week 4 results were descriptive only. FASENRA demonstrated greater improvements in change from baseline in pre-bronchodilator FEV1 compared with placebo at Week 4 (first measured time point after administration of treatment dose) that were maintained through end of treatment.2-4

*Statistical significance for FEV1 improvement was established at end of treatment. Week 4 results were descriptive only. FASENRA demonstrated greater improvements in change from baseline in pre-bronchodilator FEV1 compared with placebo at Week 4 (first measured time point after administration of treatment dose) that were maintained through end of treatment.2-4

ACCORDING TO THE FASENRA PRESCRIBING INFORMATION, REDUCTION IN EXACERBATION RATES WERE OBSERVED WITH FASENRA IRRESPECTIVE OF BASELINE PERIPHERAL EOSINOPHIL COUNTS.1

The analysis of exacerbation rates across eosinophil levels is not multiplicity protected. The primary endpoint for Trials 1 and 2 was the rate of asthma exacerbations in patients with baseline blood eosinophil counts ≥300 cells/µL who were taking high-dose ICS and LABA. Patients with a baseline blood eosinophil count ≥300 cells/μL showed a numerically greater response than those with counts <300 cells/μL.1

FASENRA demonstrated an adverse event profile similar to placebo in year 1, maintained in year 2.1,5LEARN MORE

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IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS Known hypersensitivity to benralizumab or excipients.

Warnings and Precautions

Hypersensitivity Reactions Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days). Discontinue in the event of a hypersensitivity reaction.

IMPORTANT SAFETY INFORMATION

Contraindications

Known hypersensitivity to benralizumab or excipients.

Warnings and Precautions

Hypersensitivity Reactions

Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days). Discontinue in the event of a hypersensitivity reaction.

Acute Asthma Symptoms or Deteriorating Disease

FASENRA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

Reduction of Corticosteroid Dosage

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection

It is unknown if FASENRA will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until infection resolves.

Adverse Reactions

The most common adverse reactions (incidence ≥ 5%) include headache and pharyngitis.

Injection site reactions (eg, pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients treated with placebo.

Use in Specific Populations

The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.

INDICATION

FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.

FASENRA is not indicated for treatment of other eosinophilic conditions

FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus

†At baseline of the phase 3 extension trial, in patients with baseline eosinophil ≥300 cells/μL in Trials 1 and 2 who continued on FASENRA every 8 weeks (n=339), the median eosinophil level was 0 cells/μL, which was maintained through Week 56.4,5

‡The effect of treatment on sputum eosinophil was evaluated in a sub-study of Trial 3. Patients were randomized to receive benralizumab 30 mg SC every 4 weeks (Q4W), every 8 weeks (Q8W; first 3 doses Q4W) or placebo Q4W. In a combined analysis of the benralizumab 30 mg Q4W and Q8W groups, median sputum eosinophil were depleted for patients treated with benralizumab from 4.90% (n=18) at baseline to 0.0% (n=16) at Week 12, and 0.15% (n=8) at Week 28. For patients who received placebo, median sputum eosinophil counts increased from 4.90% (n=8) at baseline to 17.55% (n=4) at Week 12, and 12.15% (n=4) at Week 28. Results are descriptive only.6

*Data from the 2005 to 2006 annual survey of a nationally representative sample of a noninstitutionalized United States population in patients with asthma (aged 18-64 years) identified based on the participants’ self-report. Eosinophilic asthma was defined as a blood eosinophil cutoff point of ≥150 cells/μL. Of the 310 adult patients, 69% had a blood eosinophil level ≥150 cells/μL.1

In Trials 1 and 2, FASENRA and placebo were administered plus standard of care (SOC), which is defined as high-dose (Trial 1) to medium- to high-dose (Trial 2) ICS/LABA (inhaled corticosteroids/long-acting β2-agonist) with or without other controllers, including systemic steroids. In Trial 3, FASENRA and placebo were administered in addition to daily OCS (7.5 to 40 mg) plus SOC, which is defined as high-dose ICS/LABA with or without other controllers.1

While 2 dosing regimens were studied in all 4 trials, the recommended dosing regimen is FASENRA administered every 4 weeks for the first 3 doses, then every 8 weeks thereafter.1

*A clinically significant exacerbation was defined as worsening of asthma requiring use of steroids for at least 3 days, and/or emergency department visits requiring use of steroids and/or hospitalization. For patients on maintenance OCS, an exacerbation was defined as a temporary increase in stable oral/systemic corticosteroids for at least 3 days or a single depo-injectable dose of corticosteroids.1

†The primary analysis population in Trial 1 was 267 for FASENRA + SOC and 267 for the placebo + SOC arm. In Trial 2, the primary analysis population for FASENRA + SOC and placebo + SOC was 239 and 248, respectively.1

‡Atopic status for the placebo groups in Trials 1, 2, and 3 was 57%, 65%, and 49%, respectively.2-4

§Allergic rhinitis for the placebo groups in Trials 1, 2, and 3 was 54%, 56%, and 40%, respectively.2-4

IIIn a post hoc analysis of Trials 1 and 2, comorbid allergic conditions were determined from medical history and respiratory disease characteristics.7

FASENRA and placebo were administered plus standard of care (SOC), which is defined as high-dose ICS/LABA (inhaled corticosteroids/long-actingβ2-agonist) with or without other controllers, including systemic steroids.1 In the phase 3 extension trial, patients from Trials 1 and 2 were to be maintained on their same dose of ICS/LABA.5

†In patients with baseline eosinophils ≥300 cells/μL in Trials 1 and 2 who continued on FASENRA every 8 weeks (n=339). Final pre-bronchodilator FEV1 assessment was at Week 48 (interim analysis for adolescents; n=310 [adults and adolescents]) and at Week 56 (end of treatment for adults; n=291).5

*In a US survey study, 47 adult patients with severe asthma and 25 board-certified physicians (ie, pulmonologists and allergists) were interviewed to understand their perceptions of biologic therapies and preferences in relation to biologic therapy attributes in the treatment of severe, uncontrolled asthma. Key attributes included dosing frequency, number of injections per treatment, delivery route, medication administration, and process required for administration.2